Relugolix to improve PSMA PET/CT imaging in men with high or very high risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized phase II trial uses flotufolastat F-18 (POSLUMA) PET/CT scans before and after a short course of relugolix to measure changes in PSMA uptake. Patients are randomized to one of three arms, including two short-course relugolix schedules (5 days or 10 days) with pre- and post-treatment PET/CT and a comparator arm. The primary endpoint compares SUVmax and SUVmean of the dominant primary prostate lesion pre- versus post-ADT; secondary endpoints include lymph node sensitivity and PSMA avidity on PET/CT. Participants typically undergo robotic radical prostatectomy with pelvic lymph node dissection within 90 days of the second PET/CT, and blood and tissue biospecimens are collected for correlative analyses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years
* Histological confirmation of prostate adenocarcinoma
* Diagnosis of high risk or very high risk prostate cancer per National Comprehensive Cancer Network (NCCN) Risk Stratification. \[Any of the following: grade group 4 or 5, prostate-specific antigen (PSA) greater than 20, radiographic cT3 on MRI\]
* Testosterone greater than or equal to 300
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Hemoglobin ≥ 9.0 g/dL (obtained ≤ 120 days prior to registration/randomization)
* Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained ≤ 120 days prior to registration/randomization)
* Platelet count ≥ 100,000/mm\^3 (obtained ≤ 120 days prior to registration/randomization)
* Male patients who are committed to undertaking the following measures for the duration of the study and after the last dose of ORGOVYX (relugolix) for the time period specified:

  * Use a condom during sex while being treated and for 30 days after the last dose of ORGOVYX (relugolix)
  * Do not make semen donations during treatment and for 30 days after the last dose of ORGOVYX (relugolix)
  * Those with female partners of childbearing potential may be enrolled if they are:

    * Documented to be surgically sterile (i.e., vasectomy);
    * Committed to practicing true abstinence during treatment and for 30 days after the last ORGOVYX (relugolix) dose; or
    * Committed to using an effective method of contraception with their partner during treatment and for 30 days following the last dose of ORGOVYX (relugolix)
* Provide written informed consent

Exclusion Criteria:

* Any of the following prior therapies:

  * Chemotherapy ≤ 2 weeks prior to registration/randomization
  * Androgen deprivation therapy
  * Pelvic radiation
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Uncontrolled intercurrent illness including, but not limited to:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
  * Or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* Other active malignancy ≤ 1 year prior to registration

  * EXCEPTIONS: Non-melanotic skin cancer
  * NOTE: If there is a history of prior malignancy, they must not be receiving other active treatment for their cancer
* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* Use of P-glycoprotein inhibitors

Where it's running

• Mayo Clinic in Arizona
  Scottsdale, Arizona, United States Recruiting

Study contacts

• Principal investigator: Jack R. Andrews, MD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining high dose-rate brachytherapy and stereotactic body radiotherapy for prostate cancer treatment

  This study is testing whether combining two types of radiation therapy can improve treatment outcomes for men with prostate cancer.

  Recruiting Jonsson Comprehensive Cancer Center · Los Angeles, California · NCT04945642

• Home versus clinic cancer treatment for Black men with advanced or recurrent prostate cancer

  This Phase II test tries whether giving cancer treatments at home instead of in the clinic is safer and more satisfying for Black men with locally advanced, biochemically recurrent, or metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Jacksonville, Florida · NCT07073794

• Comparing the effects of relugolix and leuprolide on heart health in prostate cancer patients

  This study is testing whether relugolix or leuprolide is better for heart health in men with prostate cancer who are also getting radiation treatment.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT06330805

• Comparing Abiraterone with Prednisone or Darolutamide for Advanced Prostate Cancer

  This study is testing whether a combination of abiraterone and prednisone works better than darolutamide alone for people with advanced prostate cancer by looking at side effects and changes in PSA levels over a year.

  Recruiting Phase 2 University of California, Davis · Sacramento, California · NCT06173362

• Comparing shorter radiation therapy to standard radiation for high-risk prostate cancer

  This study is testing if a shorter, more intense radiation treatment for high-risk prostate cancer can work just as well as the standard longer treatment.

  Recruiting at 431 sites Phase 3 NRG Oncology · Birmingham, Alabama and 435 other locations · NCT05946213

• Using bright white light therapy to reduce fatigue and depression in advanced prostate cancer patients

  This study is testing if bright white light therapy can help reduce fatigue and depression in men with advanced prostate cancer who are receiving treatment.

  Recruiting Phase 2 City of Hope Medical Center · Duarte, California · NCT05869682

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.